Akebia Therapeutics Update on Vafseo for Non-Dialysis Patients

On October 28, 2025, Akebia Therapeutics, Inc. announced that it will not initiate the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) not on dialysis. This decision follows a Type C meeting with the U.S. Food and Drug Administration (FDA), where the company did not reach alignment on the trial design. Akebia believes that regulatory alignment would require a significantly larger number of patients, more time, and higher costs. As a result, the company does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients. Akebia remains focused on making Vafseo the standard of care for patients on dialysis.